Berry, "QMS Ordinance Document, Record, and Procedure Checklist - 126 Items" is now available for free.
Berry
Berry Co., Ltd. (Headquarters: Taito-ku, Tokyo; CEO: Hiroshi Nakano), which operates the specialized media "Pharmaceutical Affairs Information Navi" for medical device QMS and regulatory affairs, has started offering a free download of the white paper "QMS Ordinance Document, Record, and Procedure Checklist (Excel)" for medical device manufacturers.
This document lists the documents, procedures, and records required by the QMS Ordinance in the order of the document hierarchy, with the quality manual at the top. Each item includes the article number of the QMS Ordinance and the corresponding item number of ISO 13485:2016, making it directly usable for self-inspection prior to QMS conformity assessments and QMS system ordinance investigations.

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